MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC HUM 4X100MM LT FLANGED C

Catalog Number 114904

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 12/05/2016

Event Type  Injury  

Event Description

Revision surgery - due to the patient falling.The ulna component broke through the skin, so the surgeon removed everything because he feared an infection.

Manufacturer Narrative

The reason for this revision surgery was the ulna component broke through the skin and the surgeon having removed everything because he feared infection.The previous surgery and the revision detailed in this investigation occurred over 3.7 months apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) provided by zimmer-biomet, shows that the reported components used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the components that may have contributed to reported event.Attempts were made to obtain records to verify acceptable sterilization of the device(s), as of 24 mar 2017 no records from zimmer-biomet have been forwarded.The root cause of the ulna component having broken through the skin was reported as a fall.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: DISCOVERY ELBOW
• Type of Device: DISC HUM 4X100MM LT FLANGED C
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 6223335
• MDR Text Key: 63883099
• Report Number: 1644408-2016-01061
• Device Sequence Number: 1
• Product Code: JDC
• UDI-Device Identifier: 00888912225465
• UDI-Public: (01)00888912225465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114904
• Device Lot Number: 749700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 114700,LOT 226840; 114812,LOT 333180
• Patient Outcome(s): Other; Required Intervention